| Proprietary Name: |
Celsius RMT ThermoCool Catheter; Celsius ThermoCool Catheter; EZ Steer ThermoCool Catheter; EZ Steer ThermoCool NAV Catheter; NaviStar RMT ThermoCool Catheter; NAVISTAR THERMOCOOL CATHETER; ThermoCool SF Bi-Directional Catheter; ThermoCool SF Catheter; ThermoCool SF NAV Bi-Directional Catheter; ThermoCool SF NAV Catheter |
| Classification Name: |
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION |
| Product Code: |
OAE |
| Device Class: |
3 |
| Registered Establishment Name: |
BIOSENSE WEBSTER, INC.
|
| Registered Establishment Number: |
2020638
|
| Owner/Operator: |
BIOSENSE WEBSTER, INC. |
| Owner/Operator Number: |
9044811
|
| Establishment Operations: |
Manufacturer
|
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